Endoscopic Therapy vs Surveillance for Barrett's Esophagus
(SURVENT Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial requires participants to stop taking antiplatelet and anticoagulant medications before and after endoscopic procedures, based on standard guidelines. It does not specify other medications, so you may not need to stop taking them.
What data supports the effectiveness of the treatment Endoscopic Eradication Therapy for Barrett's Esophagus?
Research shows that Endoscopic Eradication Therapy (EET) is effective in treating Barrett's Esophagus by achieving complete eradication of abnormal cells, which can help prevent the progression to cancer. Studies indicate that EET is the standard care for Barrett's Esophagus-related neoplasia, with an average of three sessions needed to achieve complete eradication.12345
Is endoscopic eradication therapy (EET) safe for humans?
How is endoscopic eradication therapy different from other treatments for Barrett's esophagus?
Endoscopic eradication therapy (EET) is unique because it directly targets and removes abnormal cells in the esophagus using an endoscope (a flexible tube with a camera and tools), aiming to completely eradicate the precancerous condition known as Barrett's esophagus. Unlike other treatments that may focus on managing symptoms or preventing acid reflux, EET actively removes the problematic tissue, reducing the risk of progression to cancer.12345
What is the purpose of this trial?
The purpose of this study is to learn the best approach to treating patients with known or suspected Barrett's esophagus by comparing endoscopic surveillance to endoscopic eradication therapy.To diagnose and manage Barrett's esophagus and low-grade dysplasia, doctors commonly use procedures called endoscopic surveillance and endoscopic eradication therapy. Endoscopic surveillance is a type of procedure where a physician will run a tube with a light and a camera on the end of it down the patients throat and remove a small piece of tissue. The piece of tissue, called a biopsy, is about the size of the tip of a ball-point pen and is checked for abnormal cells and cancer cells.Endoscopic eradication therapy is a kind of surgery which is performed to destroy the precancerous cells at the bottom of the esophagus, so that healthy cells can grow in their place. It involves procedures to either remove precancerous tissue or burn it. These procedures can have side effects, so it is not certain whether risking those side effects is worth the benefit people get from the treatments.While both of these procedures are widely accepted approaches to managing the condition, there is not enough research to show if one is better than the other.Barrett's esophagus and low-grade dysplasia does not always worsen to high-grade dysplasia and/or cancer. In fact, it usually does not. So, if a patient's dysplasia is not worsening, doctors would rather not put patients at risk unnecessarily. On the other hand, endoscopic eradication therapy could possibly prevent the worsening of low-grade dysplasia into high-grade dysplasia or cancer (esophageal adenocarcinoma) in some patients. Researchers believe that the results of this study will help doctors choose the safest and most effective procedure for their patients with Barrett's esophagus and low-grade dysplasia.This is a multicenter study involving several academic, community and private hospitals around the United States. Up to 530 participants will be randomized. This study will also include a prospective observational cohort study of up to 150 Barrett's esophagus and low grade dysplasia patients who decline randomization in the randomized control trial but undergo endoscopic surveillance (Cohort 1) or endoscopic eradication therapy (Cohort 2), and are willing to provide longitudinal observational data.
Research Team
Sachin Wani, MD
Principal Investigator
University of Colorado, Denver
Nicholas J. Shaheen
Principal Investigator
University of North Carolina
Valerie Durkalski, MPH, PhD
Principal Investigator
Medical University of South Carolina
Rhonda Souza, MD
Principal Investigator
Baylor University
Eligibility Criteria
This trial is for adults over 18 with Barrett's esophagus and low-grade dysplasia, who can tolerate acid-reducing medication and stop blood thinners before endoscopic procedures. It excludes those with high-grade dysplasia or cancer, active severe esophagitis, short life expectancy, pregnancy, prior surgery or treatment on the esophagus, and certain esophageal conditions.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo either endoscopic eradication therapy or endoscopic surveillance based on randomization
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Continued monitoring of participants for progression to high-grade dysplasia or cancer
Treatment Details
Interventions
- Endoscopic Eradication Therapy
Endoscopic Eradication Therapy is already approved in European Union, United States, Canada for the following indications:
- Barrett's esophagus with dysplasia
- Early neoplasia
- Barrett's esophagus with dysplasia
- Early esophageal adenocarcinoma
- Barrett's esophagus with dysplasia
- Early neoplasia
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Baylor University
Collaborator
University of North Carolina
Collaborator
Medical University of South Carolina
Collaborator